Augment Injectable - Bone matrix implant, composite

Intended purpose

Augment Injectable Bone Graft is indicated for use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions.

Functional description

A medical device/drug combination product which is intended to be used for physically filling bone defects by providing a biocompatible, osteoconductive scaffold for new bone formation and promoting cellular in-growth into the osseous defect. Composed of a 0.5 g or 1 g matrix material comprised of 20% bovine type I collagen and 80% beta-tricalcium phosphate (100 – 300 µm mean particle diameter); and a 1.5 mL or 3 mL solution of 0.3 mg/mL rhPDGF-BB in a 20mM sodium acetate buffer.